Screening Versus Routine Practice in Detection of Atrial Fibrillation in the Elderly Population of Lieto (LietoAF)
Primary Purpose
Atrial Fibrillation, Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Subject education to pulse palpation
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring atrial fibrillation, thromboembolism, patient education
Eligibility Criteria
Inclusion Criteria:
- patient aged 75 or over
- inhabitant of Lieto
- willing to participate
Exclusion Criteria:
- chronic atrial fibrillation
- ongoing anticoagulant treatment
- permanent institutional care
Sites / Locations
- Härkätie community health center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
pulse palpation education
Arm Description
The subject is educated to pulse palpation by registered cardiac nurse. The education time is limited to 10 minutes and done according preplanned education model
Outcomes
Primary Outcome Measures
The willingness to the pulse palpation and competence independently learn to feel own pulse.
Based on learning session evaluated by nurse and objective evaluation of the learned skills by pulse-arm device and patient's pulse diary
Secondary Outcome Measures
Number of patients with new atrial fibrillation detected during the study
During the 1 year followup visit information on atrial fibrillation is gathered form the patients records and by interview
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01721005
Brief Title
Screening Versus Routine Practice in Detection of Atrial Fibrillation in the Elderly Population of Lieto
Acronym
LietoAF
Official Title
Screening Versus Routine Practice in Detection of Atrial Fibrillation in the Elderly Population of Lieto
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turku
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to evaluate the feasibility of patient education on feeling the own pulse irregularity in the elderly population of Lieto.
Prevalence of atrial fibrillation (AF) rises with age. Subjects have often symptoms like palpitation and discomfort but especially in elderly population there's significant quantity of persons who don't feel any symptoms and fail to seek for medical care for stroke prevention.
The main objectives in this study are to find out the prevalence of AF in the elderly population of Lieto, to assess the feasibility and reability of patient education on feeling one's pulse irregularity and the affect to the quality of life of the participating subjects and monitoring the possible increased burden to the public health care system.
The study contains two office visits with specified learning session and long-term phone-call follow-up.
Detailed Description
The main objectives in this study are to find out the prevalence of AF in the elderly population of Lieto, to assess the feasibility of patient education on feeling one's pulse irregularity and the affect to the quality of life of the participating subjects and monitoring the possible increased burden to the public health care system.
The study contains two office visits with specified learning session and long-term phone-call follow-up. A specially trained nurse will initially give a 10 min education on pulse palpation to each person and evaluate their capacity to learn pulse palpation. During followup visits the compliance of the patient and possible new arrhythmias plus quality of life issues are recorded and their ability of pulse palpation is evaluated by artificial hand where various kinds of pulses are transmitted.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Stroke
Keywords
atrial fibrillation, thromboembolism, patient education
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pulse palpation education
Arm Type
Other
Arm Description
The subject is educated to pulse palpation by registered cardiac nurse. The education time is limited to 10 minutes and done according preplanned education model
Intervention Type
Other
Intervention Name(s)
Subject education to pulse palpation
Intervention Description
The subject is educated to pulse palpation by registered cardiac nurse. The education time is limited to 10 minutes and done according preplanned education model.
Primary Outcome Measure Information:
Title
The willingness to the pulse palpation and competence independently learn to feel own pulse.
Description
Based on learning session evaluated by nurse and objective evaluation of the learned skills by pulse-arm device and patient's pulse diary
Time Frame
1 month control visit
Secondary Outcome Measure Information:
Title
Number of patients with new atrial fibrillation detected during the study
Description
During the 1 year followup visit information on atrial fibrillation is gathered form the patients records and by interview
Time Frame
At 1 year followup
Other Pre-specified Outcome Measures:
Title
Quality of life
Description
EQ5D based evaluation
Time Frame
1 year followup visit
Title
New atrial fibrillation at long-term followup
Description
Data on atrial fibrillation and thromboembolic complications is gathered from patient records and patient interview
Time Frame
5 year control
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patient aged 75 or over
inhabitant of Lieto
willing to participate
Exclusion Criteria:
chronic atrial fibrillation
ongoing anticoagulant treatment
permanent institutional care
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juhani K Airaksinen, Professor
Organizational Affiliation
University of Turku
Official's Role
Principal Investigator
Facility Information:
Facility Name
Härkätie community health center
City
Lieto
ZIP/Postal Code
21420
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
28915862
Citation
Jaakkola J, Virtanen R, Vasankari T, Salminen M, Airaksinen KEJ. Self-detection of atrial fibrillation in an aged population: three-year follow-up of the LietoAF intervention study. BMC Geriatr. 2017 Sep 16;17(1):218. doi: 10.1186/s12877-017-0607-0.
Results Reference
derived
PubMed Identifier
23780517
Citation
Virtanen R, Kryssi V, Vasankari T, Salminen M, Kivela SL, Airaksinen KE. Self-detection of atrial fibrillation in an aged population: the LietoAF Study. Eur J Prev Cardiol. 2014 Nov;21(11):1437-42. doi: 10.1177/2047487313494041. Epub 2013 Jun 18.
Results Reference
derived
Learn more about this trial
Screening Versus Routine Practice in Detection of Atrial Fibrillation in the Elderly Population of Lieto
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